BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URISYS 2400

    MDR report key: 1193398 · Received October 7, 2008

    Report

    Report Number
    1823260-2008-07437
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 17, 2008
    Report Date
    October 7, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JIL
    PMA / PMN Number
    K012397
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER EXPERIENCED DISCREPANT URINE LEUKOCYTE RESULTS OVER THE LAST 3-4 WEEKS. EXACT NUMBER OF PT SAMPLES AFFECTED IS UNK. TWO SAMPLES WERE AFFECTED THIS DAY. ONE PT EXAMPLE WAS PROVIDED. INITIAL RESULT WAS NEGATIVE, REPEATED ON ANOTHER ANALYZER GAVE POSITIVE RESULT. SAME SAMPLE EXAMINED MICROSCOPICALLY GAVE 29 WBC/HPF. INITIAL RESULT WAS REPORTED AND A CORRECTED REPORT WAS SENT. PT WAS NOT ADVERSELY AFFECTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE ANALYZER WAS CONTAMINATED, AND THE LED REFLECTANCE WAS LOW. HE DECONTAMINATED THE ANALYZER AND REPLACED THE LED AND CELL. PERFORMANCE TESTS WERE PERFORMED WHICH WERE WITHIN SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 URISYS 2400 AUTOMATED URINE ANALYZER-JIL JIL ROCHE DIAGNOSTICS U2400

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK